Johnson JK, Liranso T, Saylor K, et al.[@132712]
(2020) |
Randomized, double-blind, placebo-controlled, phase II study on the efficacy of SPN-812 in children with ADHD between ages 6-12 with 222 participants. The study took place over 8 weeks and participants were split into placebo and 4 treatment groups (100 mg, 200 mg, 300 mg, 400 mg) |
Decreased scores on the ADHD-RS-IV, CGI-I, and CGI-S tests across all group, including the placebo group. SS differences present in least squares average difference from baseline to tend of study in treatment group when compared to placebo group. SPN-812 is safe with only minor TEAEs reported. |
SPN-812 is statistically significant in terms of effectiveness and is a safe treatment for ADHD in children between the ages of 6-12. It is well tolerated. |
Nasser A, Liranso T, Adewole T, et al.[@132714]
(2020) |
Randomized, double-blind, placebo-controlled, phase III study on the efficacy of SPN-812 in children with ADHD (ages 6-11) with 477 participants. The study took place over 6 weeks and participants were split into placebo and 2 treatment groups (100 mg and 200 mg). |
Decreased scores on the ADHD-RS-V, CGI-S, Conners 3-PS, WFIRS-P across all groups. A SS improvement was seen the least squares average difference from baseline to tend of study in treatment group when compared to placebo group. |
SPN-812 was statistically significant in reducing the symptoms of ADHD in children between ages 6 and 11. It was also well tolerated with few, minor TEAEs. |
Nasser A, Liranso T, Adewole T, et al.[@132715]
(2021) |
Randomized, double-blind, placebo-controlled, three-arm, parallel-group, phase 3 trial was conducted to study the effect on once-daily 400 mg and 600 mg SPN-812 in adolescents with ADHD (ages 12-17) with 297 subjects over 7 weeks. There were 3 groups: the placebo group, 400 mg treatment group, 600 mg treatment group. |
SS decreased scores from baseline versus end of study were seen in the ADHD-RS-V, CGI-I, and Conners 3-PS composite T-Score only in the 400 mg group (not the 600 mg group) when compared to the placebo. |
SPN-812 was statistically significant in reducing the symptoms of ADHD. SPN-812 was well tolerated at both doses, with minor AEs. There was a discontinuation rate of 4.5% due to AEs which occurred in 9 subjects. |
Nasser A, Liranso T, Adewole T, et al.[@132716]
(2021) |
Randomized, double-blind, placebo-controlled, three-arm, parallel-group, phase 3 trial was conducted to study the effect on once-daily 200 mg and 400 mg VLX-ER in adolescents with ADHD (ages 12-17) with 310 subjects over 6 weeks. There were 3 groups: the placebo group, 200 mg treatment group, 400 mg treatment group. |
SS decreased scores from baseline versus end of study were seen in the ADHD-RS-V total score and both sub score categories for both 200 mg and 400 mg treatment groups. SS decreased scores were also seen in the CGI-I scale score for both treatment groups. The Conners 3-PS composite T-Score and the WFIRS-P showed an average score improvement in the treatment groups, but it was not SS compared to the placebo. |
VLX-ER was statistically significant in reducing the symptoms of ADHD and was well tolerated at both doses, with minor AEs. There was a discontinuation rate of 2.9% due to AEs which occurred in 6 subjects. |
Nasser A, Liranso T, Adewole T, et al.[@132717]
(2021) |
A randomized, double-blind, placebo-controlled, three-arm, parallel-group, phase 3 trial was conducted to study the effect of once-daily 200 mg and 400 mg VLX-ER in children with ADHD (ages 6-11) with 313 subjects over 8 weeks. There were 3 groups: the placebo group, 200 mg treatment group, and 400 mg treatment group. |
SS decreased scores from baseline versus the end of the study were seen in the ADHD-RS-V total score and both sub-score categories for both 200 mg and 400 mg treatment groups. SS improvement in scores was seen in the CGI-I scale score for both treatment groups. The Conners 3-PS composite T-Score showed a SS improvement in scores for the 200 mg group, so SS improvement in the 400 mg group. The WFIRS-P didn’t show a statistically significant differences between the 3 groups. |
SPN-812 was statistically significant in reducing the symptoms of ADHD and was well tolerated at both doses, with minor AEs. There was a discontinuation rate of less than 5% due to AEs. |